Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INDIBA COMPACT devices

K-Number: K243164 · 2024-11-20

ApplicantIndiba S. A. U.
Decision Date2024-11-20
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INDIBA COMPACT devices is the device name listed in this FDA 510(k) record. The listed applicant is Indiba S. A. U.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K243164. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIBA COMPACT devices?

INDIBA COMPACT devices is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Indiba S. A. U.. The 510(k) number is K243164.

When did INDIBA COMPACT devices receive FDA 510(k) clearance?

INDIBA COMPACT devices received FDA 510(k) clearance on 2024-11-20, under 510(k) number K243164.

Who is the listed applicant for INDIBA COMPACT devices?

The FDA 510(k) record lists Indiba S. A. U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INDIBA COMPACT devices?

The FDA product code for INDIBA COMPACT devices is PBX.

Other records listing Indiba S. A. U. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241107Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)K243139Reverso Pro System

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑